Bayer’s Xarelto in deep vein thrombosis treatment confirm low rates of major bleeding seen in pivotal trial

Bayer and its development partner Janssen Pharmaceuticals, Inc. Tuesday announced results from two real world studies – the non-interventional XALIA study in patients with deep vein thrombosis (DVT) and a study in patients with cancer-associated thrombosis (CAT) – both showing low rates of major bleeding and recurrent venous thromboembolism (VTE) with Xarelto (rivaroxaban). Results from the two studies were presented at the 2015 ASH Annual Meeting, and XALIA findings were also simultaneously published in the Lancet Haematology.

“On average, every 37 seconds someone in the Western world dies from a venous blood clot, so it is important we understand the effectiveness and safety of available treatment options for these potentially life-threatening blood clots in real world patient populations,” said XALIA Principal Investigator Professor Alexander G. G. Turpie, McMaster University and Hamilton Health Sciences in Hamilton, Ontario, Canada. “The real world insights from XALIA confirm the positive benefit-risk profile of rivaroxaban for the treatment of deep vein thrombosis that was established in the Phase III EINSTEIN DVT study, endorsing that these pivotal data for rivaroxaban can be translated to the patients physicians typically see in everyday clinical practice.”

“These important findings from XALIA add to the growing prospective real world insights, including the previously reported XANTUS and XAMOS studies, confirming the safety and effectiveness of Xarelto in a broad range of patients across numerous indications,” said Dr Michael Devoy, Member of the Bayer HealthCare Executive Committee and Chief Medical Officer of Bayer HealthCare. “At Bayer, we are committed to supporting physicians and the patients they see every day who are at risk of venous and arterial blood clots.”

In the recently initiated CALLISTO Clinical Research Programme Bayer is exploring the potential benefits of rivaroxaban in patients with cancer. The risk of VTE is four to seven times higher in patients with active cancer than in people of the same age without cancer. As part of the CALLISTO programme the Memorial Sloan Kettering Cancer Center in the U.S. has conducted a Quality Assurance Initiative (QAI) under which a Clinical Pathway was established to guide the use of rivaroxaban as an alternative to injectable LMWH for cancer-associated thrombosis. The study tracked a cohort of 200 patients with cancer-associated thrombosis and PE or symptomatic proximal DVT, whose full course of anticoagulation was with rivaroxaban.

In this study rates of major bleeding and recurrent VTE with rivaroxaban were relatively low based on results from randomized clinical trials with LMWH and VKA published to date. These results suggest that despite the majority of the solid tumor patients being at cancer stage IV, the safety and effectiveness of rivaroxaban is comparable to currently recommended LMWH with the advantage of reduced patient treatment burden, supporting and validating the ongoing use of the center’s Clinical Pathway Guidelines.

Both XALIA and CALLISTO add to the extensive investigation of rivaroxaban, which by the time of its completion, is expected to include more than 275,000 patients in both clinical trials and real world settings.